Serum Regucalcin Level and Chronic Hepatitis B

NCT ID: NCT05435599

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-12-01

Brief Summary

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This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Detailed Description

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Chronic hepatitis B (CHB) infection continues to be an important health problem due to its high morbidity and mortality. For this reason, it is very important to determine the appropriate timing to start antiviral therapy in patients with CHB infection and to evaluate the stage of liver fibrosis in the treatment follow-up. Liver biopsy is the gold standard for detecting liver fibrosis. Although it is generally accepted to be a safe procedure, it can cause some serious complications. For this reason, in recent years, many studies have been conducted on new noninvasive tests in the evaluation of liver fibrosis. One of them is the serum regucalcin level. Studies have shown that serum regucalcin levels increase in liver damage, but there is no study in the literature comparing liver fibrosis and serum regucalcin levels in CHB infection. This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Conditions

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Chronic Hepatitis b Liver Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Patients undergoing liver biopsy for chronic hepatitis b
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chronic Hepatitis B

Measurement of serum regucalcin level

Group Type OTHER

Serum regucalcin level

Intervention Type DIAGNOSTIC_TEST

During routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations.

Healthy Volunteers

Measurement of serum regucalcin level

Group Type OTHER

Serum regucalcin level

Intervention Type DIAGNOSTIC_TEST

During routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations.

Interventions

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Serum regucalcin level

During routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Being followed up with a diagnosis of chronic hepatitis B
* Not having a known history of liver disease who applied to our outpatient clinic for other reasons
* Having a liver biopsy
* ≥18 years

Exclusion Criteria

* \<18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fatma Çölkesen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Wei X, Yu H, Zhao P, Xie L, Li L, Zhang J. Serum regucalcin is a useful indicator of liver injury severity in patients with hepatitis B virus-related liver diseases. Braz J Med Biol Res. 2019 Sep 30;52(10):e8845. doi: 10.1590/1414-431X20198845. eCollection 2019.

Reference Type BACKGROUND
PMID: 31576907 (View on PubMed)

Yamaguchi M, Isogai M, Shimada N. Potential sensitivity of hepatic specific protein regucalcin as a marker of chronic liver injury. Mol Cell Biochem. 1997 Feb;167(1-2):187-90. doi: 10.1023/a:1006859121897.

Reference Type BACKGROUND
PMID: 9059996 (View on PubMed)

Other Identifiers

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10542

Identifier Type: -

Identifier Source: org_study_id

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